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Enrolling by Invitation

NCT Number: NCT06999304

Pilot TMS in Mild TBI

Persistent post-concussive symptoms (PPCS) involve an array of physical, cognitive, and behavioral symptoms lasting more than a month after mild traumatic brain injury (mTBI). 34-44% of people with mTBI or concussion present with a considerable burden of PPCS 3-6 months after injury. There is currently no standardized treatment for PPCS, nor FDA approved medication for any neuropsychiatric or neurocognitive symptoms associated with mTBI. Transcranial magnetic stimulation (TMS) shows promise as a treatment for PPCS; however, the current one-size-fits-all approach does not address the heterogeneity of symptoms. We propose utilization of resting state functional MRI (rs-fMRI) guided rTMS to target personalized brain networks burdened with PPCS.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of mTBI at least 4 weeks prior but not exceeding 12 months prior to the time of screening
  • Age 18-65 years at the time of mTBI
  • High burden of post concussive symptoms at time of screening, as measured by symptoms questionnaire (PCSS) ≥35*

Exclusion criteria

  • Inability to tolerate imaging; contraindication of imaging due to implants or metal
  • Seizure disorder, active alcohol or substance use disorder
  • Inability to speak and read English
  • Anything else that, in the opinion of the PI/study physician, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
  • Subject is pregnant or breast feeding
  • Subject has participated in a clinical interventional trial in the last 3 months

Treatment and study plan

Intermittent Theta Burst Stimulation

Device

MagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 80%; Intermittent theta burst - Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz; Continuous theta burst - Number of pulses per session: 1800 pulses; Pulse frequency in burst: 50 Hertz

Other names: Transmagnetic stimulation, MagVenture

Primary outcomes

  1. Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS

    Time frame: baseline

    Percentage of participants matched with anomalous parcellations based on one of the 2 top ranked burdensome symptoms/symptom profile. If an anomalous parcellation matching one of the top 2 ranked symptom profiles can be identified in at least 16 out of 20 (80%) of participants, the trial will be considered a success.

  2. Anomalous parcellations - developing the method of personalization of TMS targets for PPCS

    Time frame: baseline

    Names and number of anomalous parcellations identified using connectivity analysis and targets available to treat with TMS based on symptom profiles

  3. Distribution of complaints for PPCS

    Time frame: baseline

    Distribution of chief symptom/complaints among participants measured by concussion clinical profile (CP) screen

  4. Mapping of complaints to anomalous parcellations

    Time frame: baseline

    Mapping of chief symptom/complaints to parcellations based on literature and connective abnormalities

Secondary outcomes

  1. Feasibility - rate of completed treatment

    Time frame: 4 weeks

    Percent of participants who complete 4 out of the 5 treatment visits.

  2. Fidelity

    Time frame: 4 weeks

    Percent of participants who complete all sessions of treatment.

  3. Safety - adverse events

    Time frame: 16 weeks

    Frequency of each adverse events.

  4. Acceptability

    Time frame: 4 weeks

    This survey will be used to understand the subject's experience with TMS and whether they feel it is an acceptable form of treatment. Questions will be both open-ended and quantitative (Likert scale). In this study, participants will be asked about their level of satisfaction with various aspects of the treatment. This survey is not standardized. Scores presented as percent of subject responses. Range: [0-100]. Higher percentage indicates more acceptability to this form of treatment.

Other outcomes

  1. Explore pre-post changes concurrent with personalized TMS on PPCS - global post-concussion scale

    Time frame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment

    Pre-post change in global post-concussion scale - Rivermead Post-Concussion Symptoms Questionnaire (RPQ) from baseline to 4- and 12-weeks post-enrollment. The RPQ consists of 16 questions about symptoms experienced after a head injury, rated on a scale of 0-4. Range [0-64]. A higher score indicates more severe symptoms. A positive change from pre to post (post score-pre score=change) indicates that symptoms get worse.

  2. Explore pre-post changes concurrent with personalized TMS on PPCS - generalized anxiety

    Time frame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment

    Pre-post change in symptom specific profile scale (general anxiety disorder-7 (GAD7)) from baseline to 4- and 12-weeks post-enrollment. The GAD7 is a 7-item anxiety scale that is self-administered, valid, and an efficient tool for screening for GAD and assessing its severity in clinical practice and research. Range: [0-21] A higher score indicates more anxiety. A positive change from pre to post (post score-pre score=change) indicates that anxiety symptoms get worse.

  3. Explore pre-post changes concurrent with personalized TMS on PPCS - speed of forgetting

    Time frame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment

    Pre-post change in symptom specific profile scale (speed of forgetting (SoF)) from baseline to 4- and 12-weeks post-enrollment. The SOF quantifies the rate of episodic trace decay without the effects of learning. Content is presented as cue-pair associates and assessed through multiple-choice or verbal recall questions. This test is 8 minutes long.

    Range: [0-1]. A higher score indicates more memory impairment. A positive change from pre to post (post score-pre score=change) indicates that memory gets worse.

  4. Explore pre-post changes concurrent with personalized TMS on PPCS - CP screen

    Time frame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment

    Pre-post change in Concussion Clinical Profiles Screening (CP) from baseline to 4- and 12-weeks post-enrollment. The CP is a 29 item self report tool to assess clinical profiles associated with concussion. Range: [0-87]. A higher score indicates more severe symptoms. A positive change from pre to post (post score-pre score=change) indicates that symptoms get worse.

  5. Explore pre-post changes concurrent with personalized TMS on PPCS - respond to treatment

    Time frame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment

    Percent of participants that respond to treatment based on improvement in symptom specific scales at 1- 4- and 12-weeks post-enrollment, defined as either show minimally clinically important difference (MCID) ≥2 SD improvement from baseline at a given timepoint

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Official study title

Personalized Accelerated Theta Burst Transcardial Magnetic Stimulation in Mild Traumatic Brain Injury

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 31, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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